Actively Recruiting

Phase Not Applicable
Age: 14Years - 19Years
FEMALE
Healthy Volunteers
NCT06147973

An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents

Led by Drexel University · Updated on 2024-04-10

148

Participants Needed

1

Research Sites

202 weeks

Total Duration

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AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn about cardiovascular disease risk among adolescent girls with overweight/obesity. The main questions this trial aims to answer are: 1. Does an acceptance-based healthy lifestyle intervention demonstrate more weight loss than a health education intervention? 2. Does an acceptance-based healthy lifestyle intervention show more improvements in participants' physiological, health-related, and psychological factors compared to a health education intervention? Participants in this trial will: 1. Engage in treatment for 6-months, comprising of a mixture of in-person and remote group sessions, occurring at Drexel University or over a video-conferencing platform. 2. Complete various assessments. These include self-reported questionnaires, measures of weight, height, body composition, blood pressure, and blood lipids, and wearing of smart watches to measure sleep and physical activity. Researchers will compare the acceptance-based and health education intervention groups to see if the acceptance-based treatment will indeed be effective in improving participants' health outcomes.

CONDITIONS

Official Title

An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents

Who Can Participate

Age: 14Years - 19Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 14 to 19 years
  • Identifies as a girl
  • Body mass index (BMI) at or above the 85th percentile for age and sex
Not Eligible

You will not qualify if you...

  • Weight loss of 5% or more in the past 6 months except post-partum
  • Recent start or dosage change of medication affecting appetite or body composition in last 3 months
  • Plans to move away within the next year
  • Active cancer or cancer treatment in past 2 years (except non-melanoma skin cancer)
  • Active or chronic infections such as HIV or tuberculosis
  • Active cardiovascular disease or related hospitalizations/treatments in past 6 months
  • Active kidney disease
  • History of bariatric surgery
  • Lung diseases requiring oxygen use, such as emphysema or chronic bronchitis
  • Diagnosed type 1 or type 2 diabetes
  • Any condition that prevents physical activity
  • Diagnosed eating disorder
  • Severe mental handicap or major psychiatric conditions limiting treatment participation
  • Recent or ongoing drug or alcohol abuse or addiction
  • Currently pregnant or less than 3 months post-partum
  • Expecting possible pregnancy within next year
  • Unwillingness to promptly report possible or confirmed pregnancy during the trial

AI-Screening

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Trial Site Locations

Total: 1 location

1

Drexel University

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

S

Stephanie Manasse, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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